Plitidepsin: an orphan drug

Bibliography

• Mitsiades CS, Ocio EM, Pandiella A, et al. Aplidin®, a marine organism-derived compound with potent antimyeloma activity in vitro and in vivo. Cancer Res 2008;68(13):5216-25
   PubMed Web of Science ®Google Scholar
• Rinehart KL. Antitumor compounds from tunicates. Med Res Rev 2000;20:1-27
   PubMed Web of Science ®Google Scholar
• O’Hanlon LH. Scientists are searching the seas for cancer drugs. J Natl Cancer Inst 2006;98:662-3
   PubMedGoogle Scholar
• Lee J, Currano JN, Carroll PJ, Joullié MM. Didemnins, tamandarins and related natural products. Nat Prod Rep 2012;29(3):404-24
   PubMed Web of Science ®Google Scholar
• Amador ML, Jimeno J, Paz-Ares L, et al. Progress in the development and acquisition of anticancer agents from marine sources. Ann Oncol 2003;14(11):1607-15
   PubMed Web of Science ®Google Scholar
• Stewart JA, Low JB, Roberts JD, Blow A. A phase I clinical trial of didemnin B. Cancer 1991;68(12):2550-4
   PubMed Web of Science ®Google Scholar
• Vera MD, Joullié MM. Natural products as probes of cell biology: 20 years of didemnin research. Med Res Rev 2002;22(2):102-45
   PubMed Web of Science ®Google Scholar
• Dorr FA, Kuhn JG, Phillips J, von Hoff DD. Phase I clinical and pharmacokinetic investigation of didemnin B, a cyclic depsipeptide. Eur J Cancer Clin Oncol 1998;24(11):1699-706
   Google Scholar
• Shin DM, Holoye PY, Murphy WK, et al. Phase I/II clinical trial of didemnin B in non-small-cell lung cancer: neuromuscular toxicity is dose-limiting. Cancer Chemother Pharmacol 1991;29(2):145-9
   PubMed Web of Science ®Google Scholar
• Weiss GR, Liu PY, O'Sullivan J, et al. A randomized phase II trial of trimetrexate or didemnin B for the treatment of metastatic or recurrent squamous carcinoma of the uterine cervix: a Southwest Oncology Group trial. Gynecol Oncol 1992;45(3):303-6
   PubMed Web of Science ®Google Scholar
• Benvenuto JA, Newman RA, Bignami GS, et al. Phase II clinical and pharmacological study of didemnin B in patients with metastatic breast cancer. Invest New Drugs 1992;10(2):113-17
   PubMed Web of Science ®Google Scholar
• Depenbrock H, Peter R, Faircloth GT, et al. In vitro activity of aplidine, a new marine-derived anti-cancer compound, on freshly explanted clonogenic human tumour cells and haematopoietic precursor cells. BJC 1998;78(6):739-44
   PubMed Web of Science ®Google Scholar
• Humeniuk R, Menon LG, Mishra PJ, et al. Aplidin® synergizes with cytosine arabinoside: functional relevance of mitochondria in Aplidin® -induced cytotoxicity. Leukemia 2007;21(12):2399-405
   PubMed Web of Science ®Google Scholar
• Munoz-Alonso M, Gonzalez-Santiago L, Martinez T, et al. The mechanism of action of plitidepsin. Curr Opin Invest Drugs 2009;10(6):536-42
   PubMedGoogle Scholar
• Taraboletti G, Poli M, Dossi R, et al. Antiangiogenic activity of aplidine, a new agent of marine origin. Br J Cancer 2004;90(12):2418-24
   PubMed Web of Science ®Google Scholar
• García-Fernández LF, Losada A, Alcaide V, et al. Aplidin induces the mitochondrial apoptotic pathway via oxidative stress-mediated JNK and p38 activation and protein kinase C delta. Oncogene 2002;21(49):7533-44
   PubMed Web of Science ®Google Scholar
• Bravo SB, García-Rendueles ME, Seoane R, et al. Plitidepsin has a cytostatic effect in human undifferentiated (anaplastic) thyroid carcinoma. Clin Cancer Res 2005;11(21):7664-73
   PubMed Web of Science ®Google Scholar
• Cuadrado A, Garcia-Fernandez LF, Gonzalez L, et al. Aplidin induces apoptosis in human cancer cells via glutathione depletion and sustained activation of the epidermal growth factor receptor, Src, JNK, and p38 MAPK. J Biol Chem 2003;278(1):241-50
   PubMed Web of Science ®Google Scholar
• Gonzalez-Santiago L, Suarez Y, Zarich N, et al. Aplidin induces JNK-dependent apoptosis in human breast cancer cells via alteration of glutathione homeostasis, Rac1 GTPase activation, and MKP-1 phosphatase downregulation. Cell Death Differ 2006;13(11):1968-81
   PubMed Web of Science ®Google Scholar
• Broggini M, Marchini SV, Galliera E, et al. Aplidine, a new anticancer agent of marine origin, inhibits vascular endothelial growth factor (VEGF) secretion and blocks VEGF-VEGFR-1 (flt-1) autocrine loop in human leukemia cells MOLT-4. Leukemia 2003;13:52-9
   Google Scholar
• Bresters D, Broekhuizen AJ, Kaaijk P, et al. In vitro cytotoxicity of aplidin and crossresistance with other cytotoxic drugs in childhood leukemic and normal bone marrow and blood samples: a rational basis for clinical development. Leukemia 2003;17(7):1338-43
   PubMed Web of Science ®Google Scholar
• Losada A, Mopez-Oliva JM, Sanchez-Puelles JM, Garcia-Fernandez LF. Establishment and characterisation of a human carcinoma cell line acquired resistance to Aplidin. Br J Cancer 2004;91(7):1405-13
   PubMed Web of Science ®Google Scholar
• Biscardi M, Caporale R, Balestri F, et al. VEGF inhibition and cytotoxic effect of Aplidin® in leukemia cell lines and cells from acute myeloid leukemia. Ann Oncol 2005;16(10):1667-74
   PubMed Web of Science ®Google Scholar
• Barboza NM, Medina DJ, Budak-Alpdogan T, et al. Plitidepsin (Aplidin) is a potent inhibitor of diffuse large cell and Burkitt lymphoma and is synergistic with rituximab. Cancer Biol Ther 2012;13(2):114-22
   PubMed Web of Science ®Google Scholar
• Morande PE, Zanetti SR, Borge M, et al. The cytotoxic activity of Aplidin® in chronic lymphocytic leukemia (CLL) is mediated by a direct effect on leukemic cells and and indirect effect on monocyte-derived cells. Invest New Drugs 2012;30:1830-40
   PubMed Web of Science ®Google Scholar
• Rockwell S, Liu Y. Aplidin as a potential adjunct to radiation therapy: in vitro studies. Int J Radiat Biol 2010;86(1):63-70
   PubMed Web of Science ®Google Scholar
• Caers J, Menu E, De Raeve H, et al. Antitumour and antiangiogenic effects of aplidin in the 5TMM syngeneic models of multiple myeloma. Br J Cancer 2008;98(12):1966-74
   PubMed Web of Science ®Google Scholar
• Verruci Verrucci M, Pancrazzi A, Aracil M, et al. CXCR4-independent rescue of the myeloproliferative defect of the Gata1low myelofibrosis mouse model by Aplidin. J Cell Physiol 2010;225(2):490-9
   PubMed Web of Science ®Google Scholar
• Brandon EF, Sparidans RW, van Ooijen RD, et al. In vitro characterization of the human biotransformation pathways of aplidine, a novel marine anti-cancer drug. Invest New Drugs 2007(1):9-19
   PubMed Web of Science ®Google Scholar
• Brandon EFA, van Ooijen RD, Sparidans RW, et al. Structure elucidation of aplidine metabolites formed in vitro by human liver microsomes using triple quadrupole mass spectrometry. J Mass Spectrom 2005;40:821-31
   PubMed Web of Science ®Google Scholar
• Nalda-Molina R, Valenzuela B, Ramon-Lopez A, et al. Population pharmacokinetics meta-analysis of plitidepsin (Aplidin) in cancer subjects. Cancer Chemother Pharmacol 2009;64(1):97-108
   PubMed Web of Science ®Google Scholar
• Faivre S, Chièze S, Delbaldo C, et al. Phase I and pharmacokinetic study of aplidine, a new marine cyclodepsipeptide in patients with advanced malignancies. J Clin Oncol 2005;23(31):7871-80
   PubMed Web of Science ®Google Scholar
• Izquierdo MA, Bowman A, García M, et al. Phase I clinical and pharmacokinetic study of plitidepsin as a 1-hour weekly intravenous infusion in patients with advanced solid tumors. Clin Cancer Res 2008;14(10):3105-12
   PubMed Web of Science ®Google Scholar
• Maroun JA, Belanger K, Seymour L, et al. Phase I study of Aplidine in a dailyx5 one-hour infusion every 3 weeks in patients with solid tumors refractory to standard therapy. A National Cancer Institute of Canada Clinical Trials Group study: NCIC CTG IND 115. Ann Oncol 2006;17(9):1371-8
   PubMed Web of Science ®Google Scholar
• Anthoney A, Paz-Ares L, Twelves C, et al. Phase I and pharmacokinetic study of Aplidin® using a 24 hour weekly schedule [Abstract 734]. Proc Am Soc Clin Oncol 2000;19:189
   Google Scholar
• Ciruelos E, Twelves C, Dominguez M, et al. Phase I clinical and pharmacokinetic study of the marine compound APL (APL) administered as a 3 hour infusion every 2 weeks. Proc Am Soc Clin Oncol 2002;21:Abstract 422
   Google Scholar
• Salazar R, Plummer R, Oaknin A, et al. Phase I study of weekly plitidepsin as 1-hour infusion combined with carboplatin in patients with advanced solid tumors or lymphomas. Invest New Drugs 2011;29(6):1406-13
   PubMed Web of Science ®Google Scholar
• Geoerger B, Estlin EJ, Aerts I, et al. A phase I and pharmacokinetic study of plitidepsin in children with advanced solid tumours: an Innovative Therapies for Children with Cancer (ITCC) study. Eur J Cancer 2012;48(3):289-96
   PubMed Web of Science ®Google Scholar
• Le Tourneau C, Faivre S, Ciruelos E, et al. Reports of clinical benefit of plitidepsin (Aplidin®), a new marine-derived anticancer agent, in patients with advanced medullary thyroid carcinoma. Am J Clin Oncol 2010;33(2):132-6
   PubMed Web of Science ®Google Scholar
• Baudin E, Droz JP, Paz-Ares L, et al. Phase II study of plitidepsin 3-hour infusion every 2 weeks in patients with unresectable advanced medullary thyroid carcinoma. Am J Clin Oncol 2010;33(1):83-8
   PubMed Web of Science ®Google Scholar
• Tabernero JM, Rivera F, Climent MA, et al. Marine- derived compounds plitidepsin 5 mg/m2 (Arm A) versus 7 mg/m2 plus L-carnitine (Arm B): phase II randomised trial in advanced and colorectal cancer [abstract 449P]. Ann Oncol 2006;17:ix144
   Web of Science ®Google Scholar
• Schöffski P, Guillem V, Garcia M, et al. Phase II randomized study of Plitidepsin (Aplidin®), alone or in association with L-carnitine, in patients with unresectable advanced renal cell carcinoma. Mar Drugs 2009;7(1):57-70
   PubMed Web of Science ®Google Scholar
• Dumez H, Gallardo E, Culine S, et al. Phase II study of biweekly plitidepsin as second-line therapy for advanced or metastatic transitional cell carcinoma of the urothelium. Mar Drugs 2009;7(3):451-63
   PubMed Web of Science ®Google Scholar
• Eisen T, Thomas J, Miller WH Jr, et al. Phase II study of biweekly plitidepsin as second-line therapy in patients with advanced malignant melanoma. Melanoma Res 2009;19(3):185-92
   PubMed Web of Science ®Google Scholar
• Plummer ER, Lorigan P, Hayward L, et al. Plitidepsin (APL) alone or with dacarbazine (DTIC) as first-line treatment for advanced unresectable melanoma (AUM) [abstract 8537]. J Clin Oncol 2010;28(Suppl):15s
   PubMedGoogle Scholar
• Peschel C, Hartmann JT, Schmittel A, et al. Phase II study of plitidepsin in pretreated patients with locally advanced or metastatic non-small cell lung cancer. Lung Cancer 2008;60(3):374-80
   PubMed Web of Science ®Google Scholar
• Eisen T, Thatcher N, Leyvraz S, et al. Phase II study of weekly plitidepsin as second-line therapy for small cell lung cancer. Lung Cancer 2009;64(1):60-5
   PubMed Web of Science ®Google Scholar
• Mateos MV, Cibeira MT, Richardson PG, et al. Phase II clinical and pharmacokinetic study of plitidepsin 3-hour infusion every two weeks alone or with dexamethasone in relapsed and refractory multiple myeloma. Clin Cancer Res 2010;16(12):3260-9
   PubMed Web of Science ®Google Scholar
• Ribrag V, Caballero D, Ferme C, et al. Multicenter phase II study of plitidepsin in patients with relapsed/refractory non-Hodgkin's lymphoma. Haematologica 2010;98(3):357-63
   Google Scholar